The purpose of this study is to determine whether 12 weeks of daily home use of the FM220 in the most affected leg of patients with PAD and claudication, will improve peak walking time (PWT) at three months as compared with a non-treated control group.

If the patient is under claudication drug therapy (eg. cilostazol and pentoxifvlline) the use and dose of these drugs has been stable for the last 60 days.

If the patient is receiving of statin and antiplatelet therapy, the use and dose of these drugs has been stable for the last 60 days.

Exclusion Criteria:

Any active pathological heart, muscular, neurological, orthopedic, cognitive or pulmonary disease which might interfere with patient compliance or ability to walk on a treadmill in the opinion of the investigator.

Non compressible arteries as defined by ABI>1.1

Clinical evidence of acute or subacute superficial or deep venous thrombosis confirmed by continuous-wave Doppler in the affected extremity.

Deep venous insufficiency on clinical grounds or by lab measurements.

Prior below-knee surgical revascularization procedure within the last 6 months.

Significant likelihood of lower extremity arterial revascularization procedure within the next 6 months.

Ulcer, cellulitis, skin conditions, or superficial thrombophlebitis in regions covered by the compression device preventing use of the device.

Acute pulmonary embolism.

Osteomyelitis of the lower extremity.

Gangrene of the lower extremity.

Acute limb ischemia.

Clinical scenarios in which increased venous or lymphatic return is undesirable.

Painful calf conditions which would exclude use of the pump.

Peripheral neuropathy that, in the opinion of the investigator, would prevent patient from accurately assessing claudication symptoms or identifying Cutaneous comfort of the device Vein ligation.

Pulmonary edema.

Significant aorto-iliac disease as demonstrated by physical examination or objective testing. Absence of aorto-iliac disease must be documented by segmental testing performed within 90 days of study enrollment.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00146666